Associate Regulatory Program Director in Mississauga

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A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

In the position of Associate Regulatory Program Director in Pharma Technical Regulatory (PTR), you will be accountable for handling all Health Authority interactions pertaining to CMC Information (for example in an IND, IMPD and NDA/BLA/MAA filings), as well as informational and/or pre-submission meetings with global Health Authorities, partners and industry experts. This role requires leadership in partnering with key stakeholders, working on both synthetic and biologic products with opportunities to work across the product lifecycle, collaborating with affiliates, and partnering with the Policy team to influence Health Authorities.

The Opportunity:

• You will be responsible for submission of high-quality CMC regulatory documents to health authorities globally according to current Good Manufacturing Practices (cGMP), Roche corporate standards, and the requirements of applicable health authorities and other regulatory agencies.
• You will develop, communicate and execute robust regulatory strategies that align with global regulatory requirements.
• You will also be accountable for the compliance and accuracy of the data in regulatory documents and in regulatory information management systems.
• You will contribute to the success of technical regulatory squad outcomes and to the timely regulatory approval of Roche products and contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
• You will be required to understand the structure, key roles and responsibilities of local and international regulators, global health authority regulations and ICH guidelines as well as support departmental business processes to document and improve best practices and work efficiency.
• You will oversee timely responses to Health Authority questions received from major/global regulators while ensuring excellence in regulatory compliance throughout the product lifecycle and support cross-functional compliance processes to maintain right to operate.

Who you are:

• You will have a Bachelor’s Degree in life science disciplines.
• A minimum of 5 years of industry experience in technical regulatory CMC.
• You will have experience in developing global regulatory strategies and scenario planning with robust regulatory risk assessment.
• Your strengths lie in knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities.
• You will have technical understanding of drug substance, product manufacturing, critical quality attributes, control system, process changes, and comparability.
• In addition, you will also have general knowledge of drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.

Preferred:

• Biologics, Device or Peptide experience would be considered a strong asset.
• A Postgraduate Degree is a plus.

Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Mississauga is 115,328.00 and 151,368.00 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

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